[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6664 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 6664
To encourage innovation in the development of pediatric drugs, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 7, 2023
Ms. Eshoo (for herself and Mr. McCaul) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To encourage innovation in the development of pediatric drugs, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Innovation in Pediatric Drugs Act of
2023''.
SEC. 2. PEDIATRIC STUDIES OF ORPHAN DRUGS.
(a) Application of Pediatric Research Requirements to Orphan
Drugs.--
(1) In general.--Section 505B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355c) is amended by striking
subsection (k).
(2) Applicability.--The amendment made by paragraph (1)
applies only to applications described in subparagraph (A) or
(B) of section 505B(a)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c(a)(1)) that are submitted on or
after the date that is 18 months after the date of enactment of
this Act.
(b) Guidance.--The Secretary of Health and Human Services (referred
to in this Act as the ``Secretary'') shall--
(1) not later than 6 months after the date of enactment of
this Act, issue draft guidance describing how, upon the
applicability of the amendment made by subsection (a)(1), the
requirements of section 505B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c) will apply with respect to any
drug or biological product for an indication for which orphan
designation has been granted under section 526 of such Act (21
U.S.C. 360bb); and
(2) not later than 18 months after the date of enactment of
this Act, finalize such draft guidance.
(c) Content of Guidance.--The guidance under subsection (b) shall
address the following:
(1) Information regarding how full and partial waivers
under subsections (a)(5)(A), (a)(5)(B), and (b)(2) of section
505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c) for any drug or biological product for an indication for
which orphan designation has been granted under section 526 of
such Act (21 U.S.C. 360bb) will be granted (including a
description of impossible or highly impracticable studies for
indications for which orphan designation has been granted under
such section 526).
(2) Application of the requirements of section 505B(e) of
such Act (21 U.S.C. 355c(e)) to drugs or biological products
for an indication for which orphan designation has been granted
under section 526 of such Act (21 U.S.C. 360bb), including
submission and timing of planned requests for full or partial
waivers and responses by the Food and Drug Administration to
those requests.
(3) Process for regularly updating conditions that
automatically qualify for a waiver under subsection (a)(5)(A)
or (b)(2)(A) of section 505B of such Act (21 U.S.C. 355c).
(4) Situations where the initial pediatric study plan under
section 505B(e) of such Act (21 U.S.C. 355c(e)) includes a plan
to study the drug or biological product in all relevant
pediatric age groups.
(5) Consideration of how the Secretary of Health and Human
Services will balance the unique scientific challenges of rare
disease drug development with the need for improved pediatric
labeling of drugs and biological products for indications for
which orphan designation has been granted under section 526 of
such Act (21 U.S.C. 360bb).
(6) Applicability of real-world evidence in the fulfillment
of requirements under section 505B of such Act (21 U.S.C.
355c).
(7) Consideration of input received from the public meeting
set forth in subsection (d).
(d) Public Meeting.--The Secretary shall--
(1) not later than 1 year after the date of enactment of
this Act, hold a public meeting to inform the final guidance to
be issued under subsection (b)(2); and
(2) publish prior notice of such meeting in the Federal
Register.
(e) GAO Study.--Not later than 4 years after the date of enactment
of this Act, the Comptroller General of the United States shall submit
to the Committee on Energy and Commerce and the Committee on Ways and
Means of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report that--
(1) addresses the impacts of this Act on--
(A) rare disease drug development in the United
States; and
(B) the increased availability of pediatric
information on drugs and biological products for
indications for which orphan designation has been
granted under section 526 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bb); and
(2) includes--
(A) the findings of a survey of companies of
varying sizes engaged in the development of orphan
drugs; and
(B) input from patient groups and medical provider
associations.
(f) Rule of Construction.--Nothing in this section shall be
construed to limit requirements for investigations, as described in
section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(a)(3)), of molecularly targeted pediatric cancer drugs for
which orphan designation has been granted under section 526 of such Act
(21 U.S.C. 360bb).
SEC. 3. REAUTHORIZING THE PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
284m(d)(1)) is amended in paragraph (1) by striking ``$25,000,000 for
each of fiscal years 2023 through 2027'' and inserting ``$50,000,000
for each of fiscal years 2023 through 2027''.
SEC. 4. ENSURING COMPLETION OF PEDIATRIC STUDY REQUIREMENTS.
(a) Equal Accountability for Pediatric Study Requirements.--Section
505B(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c(d)(2)) is amended by striking ``(except that the drug or
biological product shall not be subject to action under section 303)''.
(b) Conforming Amendments.--Section 303(f)(4)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(4)(A)) is amended by
striking ``or 505-1'' and inserting ``505-1, or 505B''.
(c) Transition Rule.--The Secretary of Health and Human Services
shall take no enforcement actions under section 303 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333) for failures described in
section 505B(d) of such Act (21 U.S.C. 355c(d)) before the date this is
180 days after the date of enactment of this Act.
SEC. 5. FDA REPORT ON PREA ENFORCEMENT.
Section 508(b) of the Food and Drug Administration Safety and
Innovation Act (21 U.S.C. 355c-1(b)) is amended--
(1) in paragraph (11), by striking the semicolon at the end
and inserting ``, including an assessment of the
appropriateness of deferrals and deferral extensions granted
for such products and an evaluation of compliance with
deadlines provided for in such deferrals and deferral
extensions;'';
(2) in paragraph (15), by striking ``and'' at the end;
(3) in paragraph (16), by striking the period at the end
and inserting ``; and''; and
(4) by adding at the end the following:
``(17) a listing of penalties, settlements, or payments
under section 303 of the Federal Food, Drug, and Cosmetic Act
for failure to comply with requirements under section 505B of
such Act, including for each penalty, settlement, or payment
the name of the drug, the sponsor thereof, and the amount of
the penalty, settlement, or payment imposed.''.
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